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Nebulized 3% Hypertonic Saline Versus Normal Saline in Managing Children With Acute Bronchiolitis: A Randomized Controlled Trial

University Of Anbar · 2025
ClinicalTrials.gov · Datasets · License: Public Domain · 2025
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narandomized-controlled-trial
This randomized controlled trial was conducted at A-Ramadi Teaching Hospital for Maternity and Children on patients admitted with acute bronchiolitis. The study covered a duration of 6 months. The study was approved by the Ethical Approval Committee of the University of Anbar. Informed consent was obtained from each parent. The severity of bronchiolitis was assessed based on the absence (score = 0) or presence (score = 1) of the following parameters: tachycardia, wheezing, use of accessory muscles, low oxygen saturation (SpO₂ \< 95%), and feeding difficulties. The total score, therefore, ranged from 0 to 5. Severity was subsequently classified into three categories: Mild (0-1), patients typically discharged home without the need for hospitalization; Moderate (2-3), patients admitted to the general pediatric ward for closer observation and supportive care; and Severe (4-5), patients requiring admission to the PICU due to significant respiratory compromise, such as oxygen saturation \< 90%, intercostal recession, and wheezing requiring respiratory support \[15\]. All patients aged 0-24 months with a clinical diagnosis of bronchiolitis, defined by signs of acute respiratory distress, chest radiographic findings consistent with bronchiolitis, and a bronchiolitis severity score of (2-3), whose parents or guardians provided informed consent were enrolled in the study. Exclusion criteria were: severely ill infants requiring mechanical ventilation; age greater than 2 years; presence of chronic illnesses such as chronic renal disease, congenital heart disease, or neuromuscular disorders; immunocompromised status (including malnutrition or chronic corticosteroid use); diagnosis of asthma; prior use of corticosteroids or bronchodilators; and refusal of caregivers to participate in the trial. We calculate the required sample size according to the mean LOS of 3 days from a previous study \[5\] and aimed to detect a clinically meaningful 25% reduction (\~0.75 days), with a sta
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